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Recombinant Interferon Alfa-2b in Treating Patients With Melanoma

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ClinicalTrials.gov Identifier: NCT01460875
Recruitment Status : Completed
First Posted : October 27, 2011
Results First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
William Carson, Ohio State University Comprehensive Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Stage IA Skin Melanoma
Stage IB Skin Melanoma
Stage IIA Skin Melanoma
Stage IIB Skin Melanoma
Stage IIC Skin Melanoma
Stage IIIA Skin Melanoma
Stage IIIB Skin Melanoma
Stage IIIC Skin Melanoma
Stage IV Skin Melanoma
Interventions Biological: recombinant interferon alfa-2b
Other: laboratory biomarker analysis
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Interferon Therapy)
Hide Arm/Group Description

Patients receive recombinant interferon alfa-2b SC thrice weekly. Treatment continues for 11 months in the absence of disease progression or unacceptable toxicity.

recombinant interferon alfa-2b: Given SC

laboratory biomarker analysis: Blood for use in correlative studies approximately 30 ml 30 x 106 peripheral blood mononuclear cell (PBMCs) will be drawn on day 1 every other week during the first 12 weeks just prior to treatment and at 1 and 4 hours post therapy.

Period Title: Overall Study
Started 34
Completed 34
Not Completed 0
Arm/Group Title Treatment (Interferon Therapy)
Hide Arm/Group Description

Patients receive recombinant interferon alfa-2b SC thrice weekly. Treatment continues for 11 months in the absence of disease progression or unacceptable toxicity.

recombinant interferon alfa-2b: Given SC

laboratory biomarker analysis: Blood for use in correlative studies approximately 30 ml 30 x 106 peripheral blood mononuclear cell (PBMCs) will be drawn on day 1 every other week during the first 12 weeks just prior to treatment and at 1 and 4 hours post therapy.

Overall Number of Baseline Participants 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 34 participants
52
(22 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Female
16
  47.1%
Male
18
  52.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Hispanic or Latino
1
   2.9%
Not Hispanic or Latino
33
  97.1%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 34 participants
34
1.Primary Outcome
Title Level of Activated STAT1(Phospho-STAT1)
Hide Description Mean and 95% confidence interval will be summarized for phospho-STAT1 at a lower dose and the standard dose. The phospho-STAT1 will also be compared between the dose levels.
Time Frame up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Interferon Therapy)
Hide Arm/Group Description:

Patients receive recombinant interferon alfa-2b SC thrice weekly. Treatment continues for 11 months in the absence of disease progression or unacceptable toxicity.

recombinant interferon alfa-2b: Given SC

laboratory biomarker analysis: Blood for use in correlative studies approximately 30 ml 30 x 106 peripheral blood mononuclear cell (PBMCs) will be drawn on day 1 every other week during the first 12 weeks just prior to treatment and at 1 and 4 hours post therapy.

Overall Number of Participants Analyzed 34
Mean (95% Confidence Interval)
Unit of Measure: MU/m2
Dose I (10 MU/m2)
5.96
(0.31 to 19.1)
Dose II (4 MU/m2)
4.80
(0.11 to 21.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment (Interferon Therapy)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments The method to be developed will allow us to declare that a response at a lower dose is not inferior to that at the standard dose for a particular patient, using a patient specific inferiority test.
Statistical Test of Hypothesis P-Value .22
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Number of Patients With Adverse Events
Hide Description Determine the tolerability of adjuvant IFN-α-2b administered at an optimized dose in terms of the toxicities that are observed and the ability of patients to receive a full year of therapy.
Time Frame up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Interferon Therapy)
Hide Arm/Group Description:

Patients receive recombinant interferon alfa-2b SC thrice weekly. Treatment continues for 11 months in the absence of disease progression or unacceptable toxicity.

recombinant interferon alfa-2b: Given SC

laboratory biomarker analysis: Blood for use in correlative studies approximately 30 ml 30 x 106 peripheral blood mononuclear cell (PBMCs) will be drawn on day 1 every other week during the first 12 weeks just prior to treatment and at 1 and 4 hours post therapy.

Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
15
  44.1%
3.Secondary Outcome
Title Percentage of Patients With Correlation Between STAT1 Phosphorylation and Interferon Alfa Gene Regulation
Hide Description Levels of p-STAT1 in PBMCs were analyzed just prior to IFN-a-2b administration to determine levels that remained stable or increased over the course of dose reduction.
Time Frame Prior to treatment and 1 and 4 hours post therapy on day 1 every other week during the first 12 weeks, and then every 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Interferon Therapy)
Hide Arm/Group Description:

Patients receive recombinant interferon alfa-2b SC thrice weekly. Treatment continues for 11 months in the absence of disease progression or unacceptable toxicity.

recombinant interferon alfa-2b: Given SC

laboratory biomarker analysis: Blood for use in correlative studies approximately 30 ml 30 x 106 peripheral blood mononuclear cell (PBMCs) will be drawn on day 1 every other week during the first 12 weeks just prior to treatment and at 1 and 4 hours post therapy.

Overall Number of Participants Analyzed 34
Measure Type: Number
Unit of Measure: percentage of patients
71
4.Secondary Outcome
Title Effect of Dose-reduction on Expression of Interferon Alfa Stimulated Genes
Hide Description Evaluated using microarray analysis of patient PBMCs. Compared using the Wilcoxon signed rank test for the dose 10MU/m2
Time Frame 1 hour post therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Interferon Therapy)
Hide Arm/Group Description:

Patients receive recombinant interferon alfa-2b SC thrice weekly. Treatment continues for 11 months in the absence of disease progression or unacceptable toxicity.

recombinant interferon alfa-2b: Given SC

laboratory biomarker analysis: Blood for use in correlative studies approximately 30 ml 30 x 106 peripheral blood mononuclear cell (PBMCs) will be drawn on day 1 every other week during the first 12 weeks just prior to treatment and at 1 and 4 hours post therapy.

Overall Number of Participants Analyzed 23
Median (Full Range)
Unit of Measure: fold change
SOCS1-1 hour post 10MU-
1.5
(0.6 to 6.2)
OAS1-1 hour post 10MU-
1.6
(0.5 to 24.8)
CXCL10-1 hour post 10MU
28.7
(0.2 to 5128.0)
CD69-1 hour post 10MU
1.3
(0.4 to 12.1)
5.Secondary Outcome
Title Effect of Dose-reduction on Interferon Alfa Gene Expression
Hide Description Evaluated using microarray analysis of patient PBMCs. Compared using the Wilcoxon signed rank test for the dose 4MU/m2
Time Frame 1 hour post therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Interferon Therapy)
Hide Arm/Group Description:

Patients receive recombinant interferon alfa-2b SC thrice weekly. Treatment continues for 11 months in the absence of disease progression or unacceptable toxicity.

recombinant interferon alfa-2b: Given SC

laboratory biomarker analysis: Blood for use in correlative studies approximately 30 ml 30 x 106 peripheral blood mononuclear cell (PBMCs) will be drawn on day 1 every other week during the first 12 weeks just prior to treatment and at 1 and 4 hours post therapy.

Overall Number of Participants Analyzed 23
Median (Full Range)
Unit of Measure: fold increase
SOCS1-1 hour post 4MU
1.2
(0.4 to 17.7)
OAS1-1 hour post 4MU
1.6
(0.5 to 5.1)
CXCL10-1 hour post 4MU
6.0
(0.0 to 386.4)
CD69-1 hour post 4MU
1.3
(0.4 to 2.1)
6.Secondary Outcome
Title Effect of Dose-reduction on Interferon Alfa Gene Expression Through Marker CD69
Hide Description Evaluated using microarray analysis of patient PBMCs. Compared between doses using the Wilcoxon signed rank test.
Time Frame 4 hours post therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Interferon Therapy)
Hide Arm/Group Description:

Patients receive recombinant interferon alfa-2b SC thrice weekly. Treatment continues for 11 months in the absence of disease progression or unacceptable toxicity.

recombinant interferon alfa-2b: Given SC

laboratory biomarker analysis: Blood for use in correlative studies approximately 30 ml 30 x 106 peripheral blood mononuclear cell (PBMCs) will be drawn on day 1 every other week during the first 12 weeks just prior to treatment and at 1 and 4 hours post therapy.

Overall Number of Participants Analyzed 22
Median (Full Range)
Unit of Measure: fold increase
SOCS1- 4 hour post-10MU
1.5
(0.6 to 6.2)
OAS1-4 hour post -10MU
1.6
(0.5 to 24.8)
CXCL10-4 hour post- 10MU
28.7
(0.2 to 5128.0)
CD69-4 hour post- 10MU
1.3
(0.4 to 12.1)
7.Secondary Outcome
Title Effect of Dose-reduction on Interferon Alfa Gene Expression at Dose Level 4MU
Hide Description Evaluated using microarray analysis of patient PBMCs. Compared between doses using the Wilcoxon signed rank test.
Time Frame 4 hours post therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Interferon Therapy)
Hide Arm/Group Description:

Patients receive recombinant interferon alfa-2b SC thrice weekly. Treatment continues for 11 months in the absence of disease progression or unacceptable toxicity.

recombinant interferon alfa-2b: Given SC

laboratory biomarker analysis: Blood for use in correlative studies approximately 30 ml 30 x 106 peripheral blood mononuclear cell (PBMCs) will be drawn on day 1 every other week during the first 12 weeks just prior to treatment and at 1 and 4 hours post therapy.

Overall Number of Participants Analyzed 23
Median (Full Range)
Unit of Measure: fold increase
SOCS1-4 hour post 4MU-
1.6
(0.4 to 8.8)
OAS1-4 hour post 4MU
3.9
(0.4 to 19.1)
CXCL10-4 hour post 4MU
112.9
(0.0 to 2898.0)
CD69-4 hour post 4MU
1.5
(0.4 to 4.5)
8.Secondary Outcome
Title Clinical Role of Tumor Sensitivity to Recombinant Interferon Alfa-2b Using Cellular Levels of Jak-STAT Signaling Intermediates
Hide Description Define the clinical role of tumor sensitivity to IFN-α, patient tumor biopsies taken prior to the administration of IFN-α will be systematically evaluated for cellular levels of Jak-STAT signaling intermediates.
Time Frame Baseline and every other week prior to recombinant interferon alfa-2b administration
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected and analyzed for outcome measure
Arm/Group Title Treatment (Interferon Therapy)
Hide Arm/Group Description:

Patients receive recombinant interferon alfa-2b SC thrice weekly. Treatment continues for 11 months in the absence of disease progression or unacceptable toxicity.

recombinant interferon alfa-2b: Given SC

laboratory biomarker analysis: Blood for use in correlative studies approximately 30 ml 30 x 106 peripheral blood mononuclear cell (PBMCs) will be drawn on day 1 every other week during the first 12 weeks just prior to treatment and at 1 and 4 hours post therapy.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Interferon Therapy)
Hide Arm/Group Description

Patients receive recombinant interferon alfa-2b SC thrice weekly. Treatment continues for 11 months in the absence of disease progression or unacceptable toxicity.

recombinant interferon alfa-2b: Given SC

laboratory biomarker analysis: Blood for use in correlative studies approximately 30 ml 30 x 106 peripheral blood mononuclear cell (PBMCs) will be drawn on day 1 every other week during the first 12 weeks just prior to treatment and at 1 and 4 hours post therapy.

All-Cause Mortality
Treatment (Interferon Therapy)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Interferon Therapy)
Affected / at Risk (%) # Events
Total   22/34 (64.71%)    
Blood and lymphatic system disorders   
Myelosuppression  1  7/34 (20.59%)  7
Gastrointestinal disorders   
Nausea  1  1/34 (2.94%)  1
General disorders   
Fatigue  1  5/34 (14.71%)  5
Investigations   
Increased AST  1  2/34 (5.88%)  2
Metabolism and nutrition disorders   
Electrolyte Abnormalities  1  5/34 (14.71%)  5
Psychiatric disorders   
Neuropsychiatric Systems  1  2/34 (5.88%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Interferon Therapy)
Affected / at Risk (%) # Events
Total   34/34 (100.00%)    
Blood and lymphatic system disorders   
Mylosuppression  1  27/34 (79.41%)  27
Gastrointestinal disorders   
Nausea  1  16/34 (47.06%)  16
Vomiting  1  8/34 (23.53%)  8
Diarrhea  1  9/34 (26.47%)  9
General disorders   
Fever  1  8/34 (23.53%)  8
Fatigue  1  28/34 (82.35%)  28
Rigors/Chills  1  19/34 (55.88%)  19
Investigations   
Increased AST  1  19/34 (55.88%)  19
Metabolism and nutrition disorders   
Electrolyte Abnormalities  1  23/34 (67.65%)  23
Hyperglycemia  1  10/34 (29.41%)  10
Musculoskeletal and connective tissue disorders   
Myalgia  1  28/34 (82.35%)  28
Psychiatric disorders   
Neuropsychiatric Symptoms  1 [1]  12/34 (35.29%)  12
Skin and subcutaneous tissue disorders   
Alopecia  1  10/34 (29.41%)  10
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
including depression
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: William Carson, MD
Organization: The Ohio State University Comprehensive Cancer Center
Phone: 614-293-6306
Responsible Party: William Carson, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01460875     History of Changes
Obsolete Identifiers: NCT00634127
Other Study ID Numbers: OSU-07033
NCI-2011-03121 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: October 25, 2011
First Posted: October 27, 2011
Results First Submitted: May 4, 2018
Results First Posted: November 2, 2018
Last Update Posted: November 2, 2018